Recall Z-2917-2018 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
MOSAIQ Oncology Information System
| Date | Aug 3, 2018 |
| Status | Terminated |
| Reason | Order Status Remains Approved When Should Indicate Complete. |
| Root cause | Unknown/Undetermined by firm |
| Action | On August 2018 the firm sent letter to all their customer with the following instructions; Recommended User Action: A user with appropriate pharmacy rights can unlock the record. This blanks out the details requiring the user to re-enter the administration details previously entered. To avoid this locking issue, close the MAR window before navigating to the CWS. This document contains important information for the continued safe and proper use of your equipment. Please post this notice in a place accessible to all users, e.g. Instructions for Use, until this action is closed. Advise the app |
| Quantity | 185 |
| Distribution | AK, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, WA, WI, WV, and WY Australia, Canada, Ireland, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, and United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141572 | MOSAIQ ONCOLOGY INFORMATION SYSTEM Impac Medical Systems, Inc., Sep 5, 2014 |